Impedance monitoring for detecting pulmonary edema and thoracic congestion

• US 8,131,356 B2
• Filed: 11/07/2007
• Issued: 03/06/2012
• Est. Priority Date: 11/25/2002
• Status: Active Grant

• Current Assignee: Regents of The University of Minnesota (University of Minnesota)
• Original Assignee: Regents of The University of Minnesota (University of Minnesota)
• Inventors: Belalcazar, Andres, Patterson, Robert, Shult, Rebecca
• Primary Examiner(s): Hindenburg, Max
• Assistant Examiner(s): EISEMAN, ADAM JARED
• Application Number:
  US11/936,357
• Publication Number:
  US 20080125826A1
• Time in Patent Office: 1,581 Days
• Field of Search: 600/547, 607/9, 607/1, 607/17, 607/18, 607/19, 607/20, 607/24, 607/281
• US Class Current: 600/547
• CPC Class Codes: A61B 5/053 Measuring electrical impedance or conductance of a portion of the body
• CPC Class Codes: A61B 5/4869 Determining body composition
• CPC Class Codes: A61B 5/4878 Evaluating oedema

Abstract

An implantable medical device includes a housing for the implantable device that is sized for implantation in a chest region of a patient and includes a housing electrode. A left ventricular lead port is connectable to a proximal end of a lead having first and second insulated conductors that extend from the proximal end of the lead to corresponding first and second electrodes near a distal end of the lead. An electrical impedance measurement circuit is electrically connected to the left ventricular lead port and the housing electrode. The circuit may inject current between the first lead electrode and the housing electrode, and measure a voltage potential, created by the current injection, between the second lead electrode and the housing electrode. The ratio of the measured voltage to injected current may be used for assessing pulmonary edema. The lead electrodes may be located in a left ventricular coronary vein.

Claims

1. An implantable medical device comprising:

a housing for the implantable device sized for implantation in a chest region of a patient and comprising a housing electrode;

a left ventricular lead port into which a proximal end of a lead is connectable, the lead having first and second conductors that are insulated from one another and that extend from the proximal end of the lead to corresponding first and second electrodes positioned near a distal end of the lead;

an electrical impedance measurement circuit electrically connected to the left ventricular lead port and to the housing electrode, the circuit adapted to inject current between the first lead electrode and the housing electrode, and adapted to measure a voltage potential between the second lead electrode and the housing electrode, the voltage potential created by the current injection; and

a control module adapted to calculate a series of multiple impedance value samples over a period of time, each impedance value sample being calculated based on a measurement of the voltage potential and the current injection that created the voltage potential, and to select and store in memory of the implantable device baseline impedance value samples from the series of multiple samples, wherein the baseline impedance value samples are selected based on the selected sample corresponding to a predetermined moment of both the cardiac cycle and the respiration cycle of the patient.

2. The device of claim 1, wherein the control module is further adapted to make an edema assessment using one or more of the baseline impedance value samples and a stored edema threshold impedance value.

3. The device of claim 2, wherein the stored edema threshold value is a value programmable by telemetry link.

4. The device of claim 3, wherein the control module is further adapted such that the edema assessment comprises comparing the one or more of the baseline impedance value samples to the stored edema threshold value.

5. The device of claim 4, wherein the control module is further adapted to trigger a warning flag to be set if the one or more of the baseline impedance value samples exceeds the stored edema threshold value.

6. The device of claim 1, wherein the predetermined moment of the cardiac cycle comprises end-systole.

7. The device of claim 6, wherein the predetermined moment of the respiration cycle comprises end-expiration.

8. The device of claim 1, wherein the measurement circuit is adapted to take, during a respiration cycle, multiple measurements each at a different one of consecutive cardiac cycles at end of systole.

9. The device of claim 8, wherein the control module is adapted such that the selecting baseline impedance value samples comprises selecting a minimum voltage potential measure from the measured voltage potentials taken at end of systole during the respiration cycle.

10. The device of claim 9, wherein the control module is adapted to select baseline impedance value samples over multiple respiration cycles.

11. The device of claim 1, wherein the control module is further adapted to store in the memory of the medical device multiple baseline impedance value samples from different times.

12. The device of claim 11, wherein the different times are determined by an edema timer within the medical device, wherein the timer establishes a period of time between obtaining consecutive ones of the baseline impedance value samples to be within a range of about two hours to about three days.

13. The device of claim 11, further comprising a telemetry circuit adapted to telemeter the multiple baseline impedance value samples to an external receiver for analysis.

14. The device of claim 1, further comprising a lead having first and second conductors that are insulated from one another and that extend from the proximal end of the lead to corresponding first and second electrodes positioned near a distal end of the lead.

15. The device of claim 14, wherein the first and second electrodes are configured for positioning within a left ventricular coronary vein.

16. The device of claim 15, wherein the first and second electrodes are, respectively, first and second epicardial electrodes.

17. The device of claim 16, wherein the electrical impedance measurement circuit is adapted to inject electrical current between the first epicardial lead electrode and the housing electrode, and is adapted to measure a voltage potential created thereby between the second epicardial lead electrode and the housing electrode to make a voltage potential measurement.

18. The device of claim 17, wherein the epicardial electrodes are configured to be sutured to a wall of a left ventricle.

19. The device of claim 1, wherein the impedance measurement circuit is adapted to measure the voltage potential at a specified heart rate range.

20. The device of claim 1, wherein the impedance measurement circuit is adapted to measure the voltage potential at a specified posture of the patient, as determined by a posture sensor.

21. The device of claim 1, wherein the housing electrode is a can electrode.

22. The device of claim 1, wherein the housing electrode is a header electrode.

23. The device of claim 1, further comprising a second lead port into which a proximal end of a second lead is connectable, the second lead having first and second conductors that are insulated from one another and that extend from the proximal end of the lead to corresponding first and second electrodes positioned near a distal end of the lead;

and

wherein the electrical impedance measurement circuit is further electrically connected to the second lead port, and is adapted to inject current between the first lead electrode of the second lead and the housing electrode, and is adapted to measure a second voltage potential between the second lead electrode of the second lead and the housing electrode, the second voltage potential created by the current injection; and

wherein the control module is further adapted to calculate a second impedance value based on the second voltage potential and the current injection.

24. A system for monitoring pulmonary edema in a human being, the system comprising:

means for injecting an electrical current between a first electrode located in a coronary vein of a left ventricle and a housing of a medical device implanted in a chest region;

means for measuring a voltage potential between a second electrode located in the coronary vein of the left ventricle and the medical device housing, the voltage potential created by the electrical current injection; and

means for assessing pulmonary edema based on a baseline impedance value sample, the baseline impedance value sample selected from a series of multiple impedance values sampled over a period of time, each of the multiple impedance values being calculated based on a measurement of the voltage potential and the injected electrical current that created the voltage potential, wherein the baseline impedance value sample is selected based on the selected sample corresponding to a predetermined moment of both the cardiac cycle and the respiration cycle of the human being.

25. The system of claim 24, further comprising means for calculating an impedance value by taking a ratio of the measured voltage potential to the injected current.

26. A system for monitoring pulmonary edema in a human being, the system comprising:

means for injecting a first electrical current between a first electrode located in a coronary vein of a left ventricle and a housing of a medical device implanted in a chest region;

means for measuring a first voltage potential between a second electrode located in the coronary vein of the left ventricle and the medical device housing, the first voltage potential created by the first current injection;

means for injecting a second electrical current between a third electrode located in a right atrium and the medical device housing;

means for measuring a second voltage potential between a fourth electrode located in the right atrium and the medical device housing, the second voltage potential created by the second current injection; and

means for assessing pulmonary edema based on a stored edema threshold impedance value and a baseline impedance value sample, the baseline impedance value sample selected from a series of multiple impedance values sampled over a period of time, each of the multiple impedance values being calculated based on one or more of (i) a measurement of the first voltage potential and the first injected electrical current that created the first voltage potential, and (ii) a measurement of the second voltage potential and the second injected electrical current that created the second voltage potential, wherein the baseline impedance value is selected based on the selected sample corresponding to a predetermined moment of both the cardiac cycle and the respiration cycle of the human being.

27. The system of claim 26, further comprising:

means for calculating a first impedance value by taking a first ratio of the measured first voltage potential to the injected first current; and

means for calculating a second impedance value by taking a second ratio of the measured second voltage potential to the injected second current.

28. The system of claim 26, wherein a weighted combination of the an impedance sampled from the coronary vein of the left ventricle and an impedance sampled from the right atrium is used to assess pulmonary edema.